Combined Online Assistance for Caregiver Health (COACH): The Efficacy of a Combined Physical Activity and Coping Skills Training Intervention for Caregivers
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Caregiver Burden using Zarit Burden Inventory
研究概览
简要总结
This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals aged 18 - 85
- •distress associated with being the primary caregiver of a person with TBI or dementia
- •endorsement of at least two of the following items: felt overwhelmed, felt like needed to cry, angry or frustrated, distant or cut of from family or friends, moderate to high levels of stress, felt their health had declined
- •provide at least one hour of care (supervision or direct assistance) per week over the past three months
- •approval by Primary Care Provider to participate in physical exercise
- •be proficient in spoken and written English
排除标准
- •current or lifetime history of any psychiatric disorder with psychotic features
- •prominent suicidal or homicidal ideation
- •current alcohol or substance abuse
- •diagnosis of probable or possible dementia
- •a Short Portable Mental Status score of ≥ 8
- •participation in another caregiver intervention within the past year
- •lack of regular access to the internet
- •planned transfer of care recipient to another caregiver or nursing home within 12 months; 8) current severe cardiac disease (e.g., uncontrolled atrial fibrillation, defined as mean 24 hour heart rate >85 beats/min, or 24 hour maximal ventricular rate >150 beats/min; uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia >3 beats in succession, or 24 hour PVC count >20%; active pericarditis or myocarditis; Class III/IV heart failure and / or ejection fraction < 20%; thrombophlebitis; pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen; embolism within past 6 months)
- •inability to participate in an exercise stress test
- •morbid obesity (BMI > 39)
- •inability to read, verbalize understanding and voluntarily sign the Informed Consent.
- •Caregivers meeting any of these exclusion criteria will be excluded from all aspects of this project.
研究组 & 干预措施
Combined Aerobic and Resistance Exercise
Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry. Exercises will focus on increasing the heart rate to a point at which participants will breathe more heavily and may sweat.
干预措施: Combined Aerobic and Resistance Exercise + Caregiver Skills Training (Behavioral)
Balance and Flexibility
Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry.
干预措施: Stretching Balance and Flexibility + Caregiver Skills Training (Behavioral)
结局指标
主要结局
Caregiver Burden using Zarit Burden Inventory
时间窗: Six Months
Zarit Burden Inventory
次要结局
未报告次要终点
研究者
J. Kaci Fairchild, PhD
Principal Investigator
Palo Alto Veterans Institute for Research